Flexible Flat-Rate Plans

Flat-rate pricing for predictable budgeting

Short-term plans for project- or client-based billing

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078601

« Back to Dashboard
NDA 078601 describes ROPIVACAINE HYDROCHLORIDE, which is a drug marketed by Navinta Llc, Aurobindo Pharma Ltd, Sagent Strides, Akorn Inc, and Hospira, and is included in five NDAs. It is available from five suppliers. Additional details are available on the ROPIVACAINE HYDROCHLORIDE profile page.

The generic ingredient in ROPIVACAINE HYDROCHLORIDE is ropivacaine hydrochloride. There are twelve drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ropivacaine hydrochloride profile page.

Summary for NDA: 078601

Navinta Llc
ropivacaine hydrochloride

Pharmacology for NDA: 078601

Physiological EffectLocal Anesthesia

Suppliers and Packaging for NDA: 078601

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ropivacaine hydrochloride
SOLUTION;INJECTION 078601 ANDA Sandoz Inc 0781-3140 0781-3140-14 5 CARTON in 1 BOX (0781-3140-14) > 1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3140-30) > 30 mL in 1 VIAL, SINGLE-DOSE
ropivacaine hydrochloride
SOLUTION;INJECTION 078601 ANDA Sandoz Inc 0781-3142 0781-3142-14 5 CARTON in 1 BOX (0781-3142-14) > 1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3142-80) > 20 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTIONStrength150MG/30ML (5MG/ML)
Approval Date:Jul 17, 2014TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTIONStrength200MG/20ML (10MG/ML)
Approval Date:Jul 17, 2014TE:APRLD:No

Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.